SECTION 241.63. General HACCP Requirements

(a) Every dealer shall conduct a hazard analysis to determine the food safety hazards that are reasonably likely to occur for each kind of molluscan shellfish product processed by that dealer and to identify the preventive measures that the dealer can apply to control those hazards. Such food safety hazards can be introduced both within and outside the processing plant environment, including food safety hazards that can occur before, during, and after harvest. A food safety hazard that is reasonably likely to occur is one for which a prudent dealer would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that the hazard will occur in the particular type of molluscan shellfish product being processed in the absence of those controls.

(b) Every dealer shall have, implement, and comply with a written HACCP plan that is acceptable to the SSD. A copy of the plan shall be provided to the SSD upon request. A HACCP plan shall be specific to:

(1) each location where molluscan shellfish products are processed by that dealer; and

(2) each kind of molluscan shellfish product processed by the dealer. The plan may group kinds of molluscan shellfish products together, or group kinds of production methods together, if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed in this section are identical for all molluscan shellfish products so grouped or for all production methods so grouped.

(c) The HACCP plan shall, at a minimum:

(1) list the food safety hazards that are reasonably likely to occur, as identified in accordance with subsection (a) of this section and that must be controlled for each molluscan shellfish product. Consideration should be given to whether any food safety hazards are reasonably likely to occur as a result of the following:

(A) natural toxins;

(B) microbiological contamination;

(C) chemical contamination;

(D) pesticides;

(E) drug residues;

(F) unapproved use of direct or indirect food or color additives; and

(G) physical hazards.

(2) list the critical control points for each of the identified food safety hazards, including as appropriate:

(A) critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest. If the dealer can demonstrate to the department through a hazard analysis that the food safety hazard is not reasonably likely to occur or is otherwise controlled, the critical control point is not required; and

(B) critical control points designed to control food safety hazards that could be introduced in the processing plant environment. If the dealer can demonstrate to the department through a hazard analysis that the food safety hazard is not reasonably likely to occur, the critical control point is not required;

(3) list the critical limits that must be met at each of the critical control points;

(4) list the procedures, and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

(5) include any written corrective action plans that have been developed in accordance with this section to be followed in response to deviations from critical limits at critical control points;

(6) list the verification procedures, and frequency thereof, that the dealer will use in accordance with this section. The records shall contain the actual values and observations obtained during monitoring; and

(7) provide for a record keeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.

(d) The HACCP plan shall be signed and dated by the most responsible individual on site at the processing facility or by a higher level official of the dealer:

(1) upon initial acceptance;

(2) upon any modification; and

(3) upon verification of the plan in accordance with subsection (g)(1)(A) of this section.

(e) Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with §241.64 of this title (relating to General Sanitation Requirements), they need not be included in the HACCP plan.

(f) Corrective Actions.

(1) Whenever a deviation from a critical limit occurs, a dealer shall take corrective action either by:

(A) following a corrective action plan that is appropriate for the particular deviation; or

(B) following the procedures in paragraph (2) of this subsection.

(2) Dealers may develop written corrective action plans, which become part of their HACCP plans in accordance with subsection (c)(5) of this section, by which they predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that:

(A) no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and

(B) the cause of the deviation is corrected.

(3) When a deviation from a critical limit occurs and the dealer does not have a corrective action plan that is appropriate for that deviation, the dealer shall:

(A) segregate and hold the affected product, at least until the requirements of subparagraphs (B) and (C) of this paragraph are met;

(B) perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience to perform such a review;

(C) take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;

(D) take corrective action, when necessary, to correct the cause of the deviation; and

(E) perform or obtain timely reassessment by an individual or individuals who have been trained in accordance with this section to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.

(4) All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with subsection (g) of this section and the record keeping requirements of subsection (h) of this section.

(g) Verification.

(1) Every dealer shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur and that the plan is being effectively implemented. Verification shall include, at a minimum:

(A) a reassessment of the adequacy of the HACCP plan at least annually or whenever any changes occur that could affect the hazard analysis or alter the HACCP plan in any way. The reassessment shall be performed by an individual or individuals who have been trained in accordance with subsection (i) of this section. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan is no longer adequate to fully meet the requirements of subsection (c) of this section. These changes may include:

(i) raw materials or source of raw materials;

(ii) product formulation;

(iii) processing methods or systems;

(iv) finished product distribution systems; or

(v) the intended use or consumers of the finished product.

(B) ongoing verification activities including:

(i) a review of any consumer complaints that have been received by the dealer to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points;

(ii) the calibration of process-monitoring instruments; and

(iii) at the option of the dealer, the performing of periodic end- product or in-process testing.

(C) a review, including signing and dating, by an individual who has been trained in accordance with subsection (i) of this section, of the records that document:

(i) the monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that they document values that are within the critical limits. This review shall occur within one week of the day that the records are made;

(ii) the taking of corrective actions. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with subsection (f) of this section. This review shall occur within one week of the day that the records are made; and

(iii) the calibrating of any process-monitoring instruments used at critical control points and the performing of any periodic end product or in process testing that is part of the dealer's verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete, and that these activities occurred in accordance with the dealer's written procedures as specified in the HACCP plan. These reviews shall occur within one week of the day the records are made.

(2) Dealers shall immediately follow the procedures in subsection (f) of this section whenever any verification procedure, including the review of a consumer complaint, reveals the need to take a corrective action.

(3) The calibration of process-monitoring instruments and the performing of any periodic end-product and in-process testing, in accordance with paragraph (1)(B)(ii) and (iii) of this subsection, shall be documented in records that are subject to the record keeping requirements of subsection (h) of this section.

(h) Records.

(1) All records required shall include:

(A) the name and location of the dealer;

(B) the date and time of the activity that the record reflects;

(C) the signature or initials of the person performing the operation; and

(D) where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed.

(2) All records required shall be retained at the processing facility for at least one year after the date they were prepared in the case of refrigerated products and for at least two years after the date they were prepared in the case of frozen products.

(3) Records that relate to the general adequacy of equipment or processes being used by a processor, including the results of scientific studies and evaluations, shall be retained at the processing facility for at least two years from the date that product is first produced using the applicable equipment or processes.

(4) If the processing facility is closed for a prolonged period between seasonal operations or if record storage capacity is limited on a processing vessel or at a remote processing site, the records may be transferred to some other reasonably accessible location at the end of the seasonal operations, but shall be immediately producible for official review upon request by the department.

(5) All records required by subsection (h) of this section, and HACCP plans required by subsections (b) and (c) of this section shall be available for official review and copying upon request by the department.

(6) Tags on containers of molluscan shell stock are not subject to the requirements of this section unless they are used to fulfill the requirements of record keeping.

(7) The maintenance of records on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and electronic signatures.

(i) Training.

(1) At a minimum, the following functions shall be performed by an individual who has successfully completed training in the application of HACCP principles to molluscan shellfish processing at least equivalent to that received under standardized curriculum recognized as adequate by the FDA or who is otherwise qualified through job experience to perform these functions:

(A) developing a HACCP plan, which could include adapting a model or generic-type HACCP plan that is appropriate for a specific processor, in order to meet the requirements of subsection (c) of this section;

(B) reassessing and modifying the HACCP plan in accordance with the corrective action procedures specified in subsection (f)(3)(E) of this section, and the HACCP plan in accordance with the verification activities specified in subsection (g)(1)(B) of this section; and

(C) performing the record review required by subsection (g)(1)(C) of this section.

(2) Job experience will qualify an individual to perform these functions if he/she has provided knowledge at least equivalent to that provided through the standardized curriculum as determined by the SSD.

(3) The trained individual need not be an employee of the dealer.

Source Note: The provisions of this §241.63 adopted to be effective March 20, 2003, 28 TexReg 2346